(14 days)
No
The document describes a standard diagnostic ultrasound system and explicitly states that it does not include technology or control feature changes different from previously cleared devices operating in B-Mode or M-Mode. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" refers to it as a "diagnostic ultrasound system."
No
The device description explicitly lists hardware components including an ultrasound engine, control panel, and multiple ultrasound probes, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that uses physical principles (ultrasound waves) to create images of internal structures and analyze fluid movement within the body.
- Device Description: The description details an ultrasound system with probes and software for generating and processing ultrasound images. This aligns with in-vivo imaging, not in-vitro testing.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not mention handling or analyzing any such specimens.
The device is a diagnostic ultrasound system, which is a type of medical device used for imaging in vivo.
N/A
Intended Use / Indications for Use
The intended uses of this system and its accessories are as follows: B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
System: Seeker and Spark Ultrasound Imaging System
Transducer: Applicable to CLA4, ENDO-6.5, L10, L12, and HFLA transducers, each with specific operating frequencies detailed in their respective sections.
Clinical Applications (Mode of Operation: B, M, and combined B/M):
Fetal
Abdominal
Pediatric
Small Organ (Breast, Thyroid, Testicles)
Neonatal Cephalic
Adult Cephalic
Transrectal (only for ENDO-6.5 transducer)
Transvaginal (only for ENDO-6.5 transducer)
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Specify): 3D (for Fetal and Abdominal with CLA4 transducer; for Fetal with ENDO-6.5 transducer).
Product codes
PC 90-IYC, PC 90-ITX, IYO, ITX
Device Description
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those connonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed.
The devices included in this submission are as follows: Seeker/Spark Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a stand-alone enclosure with separate control panel, for connection to a host PC via a USB port:
A probe, 128 element convex array (for Seeker only), at an ultrasonic frequency of approximately 4 MHz, model CLA4, part number 9650-0003.
A probe, 128 element convex endocavity array at an ultrasonic frequency of approximately 6.5 MHz, model ENDO-6.5, part number 9650-0001.
A probe, 128 element linear array at an ultrasonic frequency of approximately 10 MHz, model L10, part number 9655-0003.
A probe, 128 element linear array at an ultrasonic frequency of approximately 12 MHz, model L12, part number 9655-0002.
A probe, 128 element linear array at an ultrasonic frequency of approximately 16 MHz, model HFLA, part number 9655-0004.
Software able to reside in a Windows-based PC inclusive of a non-metrological 3-D image rendering capability.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Small organ (Breast, Thyroid, Testicles), Pediatric, Cephalic (Neonatal and Adult), Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel, Transrectal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 3. The modes of operation for this system are limited to B-mode, M-Mode and combined B-M mode.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Document No .: 9830-0005-510k Revision: 1.4 Date: 28 Feb 2006
510(k) Premarket Submission
Seeker/Spark
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21 CFR, part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
Ardent Sound, Inc. 33 South Sycamore St. Mesa, AZ 85202
| Corresponding Official: | Paul Jaeger |
|---|---|
| Sr. Principal Engineer | |
| E-mail: | p.jaeger@ardentsound.com |
| Telephone: | 480-649-1806 |
| Facsimile: | 480-649-1605 |
| Date of preparation: | December 20, 2005 |
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
Seeker/Spark Ultrasound System
Classification: Regulatory Class II
Review Category: Tier II
| 21 CFR# | Prod. Code | |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | PC 90-IYC |
| Diagnostic Ultrasonic Transducer | 892.1570 | PC 90-ITX |
עמחים 1 ט
Substantial equivalence claimed to:
| Trade Name | Manufacturer | 510(k) |
|---|---|---|
| DIASUS | Dynamic Imaging Ltd | K013142 |
| AU5 | Esaote | K980468 |
| AU5/3D | Esaote | K000681 |
The Seeker/Spark is of comparable type and substantially equivalent to the legally marketed
510(k) Summary of Safety and Effectiveness
Page 1 of 3
1
Dynamic Imaging Diasus, Esaote AU5 Ultrasound Imaging System and AU5 with 3D Imaging Mode. It has the same technology characteristics, is comparable in key safety and effectiveness features, and all its intended uses and operating modes are available in the predicative devices.
Additional Substantial Equivalence Information is provided in the following Comparison to Predicate Devices table (section 4.5).
Description:
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those connonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed.
The devices included in this submission are as follows:
Seeker/Spark Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a stand-alone enclosure with separate control panel, for connection to a host PC via a USB port:
A probe, 128 element convex array (for Seeker only), at an ultrasonic frequency of approximately 4 MHz, model CLA4, part number 9650-0003.
A probe, 128 element convex endocavity array at an ultrasonic frequency of approximately 6.5 MHz, model ENDO-6.5, part number 9650-0001.
A probe, 128 element linear array at an ultrasonic frequency of approximately 10 MHz, model L10, part number 9655-0003.
A probe, 128 element linear array at an ultrasonic frequency of approximately 12 MHz, model L12, part number 9655-0002.
A probe, 128 element linear array at an ultrasonic frequency of approximately 16 MHz, model HFLA, part number 9655-0004.
Software able to reside in a Windows-based PC inclusive of a non-metrological 3-D image rendering capability.
Seeker/Spark complies with the following standards:
a) IEC 60601-1, Part 1: General requirements for safety.
2
- b) IEC 60601-1-2, Part 1: General requirements for safety, 2. Collateral standard: Electromagnetic compatibility - Requirements and tests.
- c) IEC 60601-1-4, Part 1: General requirements for safety, 4. Collateral standard: Programmable electrical medical systems.
- d) IEC 60601-2-37:2004-08 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
Intended use:
The intended uses of this system and its accessories are as follows:
B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.
Summary of technological characteristics:
There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound.
Testing:
The Seeker/Spark Ultrasound System and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced in Section 4. Prior to release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 3. The modes of operation for this system are limited to B-mode, M-Mode and combined B-M mode.
Ardent Sound, Inc. believes that the acoustic testing, conformance to the standards listed herein and Ardent's compliance to 21 CFR 820 Good Manufacturing Practices, both confirm and ensure the substantial equivalence with respect to safety and effectiveness to the predicate devices identified.
510(k) Number: None currently exists. Device Name: Seeker/Spark Ultrasound System
510(k) Summary of Safety and Effectiveness
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2006 APR
Ardent Sound, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
K060800 Re:
Trade/Device Name: Seeker/Spark Ultrasound Imaging System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasound pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: March 20, 2006 Received: March 24, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Seeker/Spark Ultrasound Imaging System as described in your premarket notification:
CLA4, 4 MHz 60mm ROC, 128 element Convex Array, PN 9650-0003 ENDO-6.5, 6.5 MHz 128 element Convex Endocavity Array, PN 9650-0001 1.10, 128 clement 10 MHz Lincar Array, PN 9655-0003 L12, 128 element 12 MHz Linear Array, PN 9655-0002 HFLA, 128 element 12-18 MHz High Frequency Linear Array, PN 9655-0004
4
Page 2 -- Ms. Laura Storms-Tyler
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
5
Page 3 – Ms. Laura Storms-Tyler
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours,
David R. Legum
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
510(k) Premarket Submission
Page 1/6
INDICATIONS FOR USE
Kobotoo
Diagnostic Ultrasound Indications for Use Form
Seeker and Spark Ultrasound Imaging System
System: Transducer
Fetal
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation Clinical Application Color Color Amplitude Combined Other PWD CWD A B M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic N N N B/M 3D
| Abdominal | N | N | N B/M | 3D | |
|---|---|---|---|---|---|
| Intraoperative (specify) | |||||
| Intraoperative Neurological | |||||
| Pediatric | N | N | N B/M | ||
| Small Organ (specify) | N Note 1 | N Note 1 | N B/M | ||
| Neonatal Cephalic | N | N | N B/M | ||
| Adult Cephalic | N | N | N B/M | ||
| Cardiac | |||||
| Transesophageal | |||||
| Transrectal | N | N | N B/M | ||
| Transvaginal | N | N | N B/M | ||
| Transurethral | |||||
| Intravascular | |||||
| Peripheral Vascular | N | N | N B/M | ||
| Laparoscopic | |||||
| Musculo-skeletal | |||||
| Conventional | N | N | N B/M | ||
| Musculo-skeletal Superficial | N | N | N B/M | ||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Note I Breast, Thyroid, Testicles
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | \✓ |
| 510(k) Number | 14260800 |
7
| Document No.: 9830-0005-510k | Seeker/Spark | Page 11 of 56 |
|---|---|---|
| Revision: 1.4 | 510(k) Premarket Submission | |
| Date: 28 Feb 2006 | Page 2/6 |
K D60800
Diagnostic Ultrasound Indications for Use Form
| System | Seeker Ultrasound Imaging System |
|---|---|
| Transducer | CLA4, 4 MHz 60mm ROC, 128 element convex array, PN 9650-0003. |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | N | N | N B/M | 3D | ||||||
| Abdominal | N | N | N B/M | 3D | ||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IF NEEDED)
·
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Prescription Use (Per 21 CFR 801 109) ﮯ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
8
| Document No.: | 9830-0005-510k | Seeker/Spark | Page 12 of 56 |
|---|---|---|---|
| Revision: | 1.4 | ||
| Date: | 28 Feb 2006 | 510(k) Premarket Submission | Page 3/6 |
Diagnostic Ultrasound Indications for Use Form
KoboBoo
| System | Seeker and Spark Ultrasound Imaging System |
|---|---|
| Transducer | ENDO-6.5, 6.5 MHz 128 element convex endocavity array, PN 9650-0001. |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N B/M | 3D | ||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N B/M | |||||||
| Transvaginal | N | N | N B/M | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: __
(PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
f CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
9
| Document No.: 9830-0005-510k | Seeker/Spark |
|---|---|
| Revision: 1.4 | |
| Date: 28 Feb 2006 | 510(k) Premarket Submission |
eeker/Spark
804
Page 13 of 56
Diagnostic Ultrasound Indications for Use Form
Kobozoo
| System: | Seeker and Spark Ultrasound Imaging System | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer | L10, 128 element 10 MHz linear array, PN 9655-0003. | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | N | N | N B/M | ||||||||
| Small Organ (specify) | N Note 1 | N Note 1 | N B/M | ||||||||
| Neonatal Cephalic | N | N | N B/M | ||||||||
| Adult Cephalic | N | N | N B/M | ||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N B/M | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N B/M | ||||||||
| Musculo-skeletal Superficial | N | N | N B/M | ||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments_ Note 1 Breast, Thyroid, Testicles
(PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IP NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
ﮐﮯ Prescription Use (Per 21 CFR 801 109)
David L. Hyam
(Division Sign-Off)
Division or Fieprobuctive, Abdominal, and Radiological Devices 510(k) Number
10
| Document No.: | 9830-0005-510k | Seeker/Spark | Page 14 of 56 |
|---|---|---|---|
| Revision: | 1.4 | ||
| Date: | 28 Feb 2006 | ||
| 510(k) Premarket Submission |
Diagnostic Ultrasound Indications for Use Form
| K060800 | page 5/6 |
|---|---|
| --------- | ---------- |
Diagnostic Ultrasound Indications for Use Form
| System: | Seeker and Spark Ultrasound Imaging System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer | L12, 128 element 12 MHz linear array, PN 9655-0002. | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N B/M | |||||||
| Small Organ (specify) | N Note 1 | N Note 1 | N B/M | |||||||
| Neonatal Cephalic | N | N | N B/M | |||||||
| Adult Cephalic | N | N | N B/M | |||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N B/M | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | N | N B/M | |||||||
| Musculo-skeletal Superficial | N | N | N B/M | |||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:______ Note } Breast, Thyroid, Testicles
(PLEASE DO NOT WRITE BELOW THIS LINE=CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) 1
David A. Sazum
(Division Sign-Off)
Division of Heproductive, Abdominal, and Radiological Devices 510(k) Number
11
| Document No.: 9830-0005-510k | Seeker/Spark | Page 15 of 56 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Revision: 1.4 | |||||||||||
| Date: 28 Feb 2006 | 510(k) Premarket Submission | page 6/6 | |||||||||
| K060800 | |||||||||||
| Diagnostic Ultrasound Indications for Use Form | |||||||||||
| Spark Ultrasound Imaging System | |||||||||||
| System: | |||||||||||
| Transducer | HFLA, 128 element 12-18MHz High Frequency Linear Array, PN 9655-0004 | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N B/M | |||||||
| Small Organ (specify) | N Note 1 | N Note 1 | N B/M | |||||||
| Neonatal Cephalic | N | N | N B/M | |||||||
| Adult Cephalic | N | N | N B/M | |||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N B/M | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | N | N B/M | |||||||
| Musculo-skeletal Superficial | N | N | N B/M | |||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Note I Breast Thyroid Testicles
(PLEASE DO NOT WRITE BELOW THIS LINE>CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Lyon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 160800 510(k) Number __